Status:
RECRUITING
Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Type 2
Prediabetic State
Eligibility:
All Genders
22-79 years
Phase:
NA
Brief Summary
This study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in glucose levels compared to a patient education control program...
Detailed Description
Type 2 diabetes mellitus (T2D) is a major cause of blindness, kidney failure, cardiovascular disease, amputations, reduced quality of life, and premature death in the United States, and it is expected...
Eligibility Criteria
Inclusion
- Age ≥ 22 years and \< 80 years of age
- Prediabetes
- Insomnia
- Regular access to device with internet access
- Adequate data at baseline
Exclusion
- BMI \> 40 kg/m2
- Sleep comorbidities detected in medical record or via medical history
- Shift work or significant, externally imposed irregular sleep schedule
- moderate to severe OSA by home sleep apnea test as part of trial protocol
- Received a full course of CBT-I in the last 12 months
- Current use of medication with glycemic effects:
- History of type 1 or type 2 diabetes or recent/planned use of hypoglycemic agents (e.g., metformin, insulin)
- Recent history of bariatric surgery or planning bariatric surgery in the next year
- Current or recent use of weight loss meds
- Unstable sleep medication regimen (recent change to schedule or dosage)
- Significant comorbidity that may interfere with CBT-I uptake or increase risks
- Unwilling or unable to limit heavy machinery use/long bouts of driving or unstable illness that would be worsened by sleep restriction
- High risk of falls
- Epilepsy
- Medical conditions that interfere with dCBT-I or contribute to insomnia or diabetes risk (e.g., hyperthyroidism, significant kidney disease, active cancer treatment, any medical condition that requires chronic steroid use)
- Significant alcohol or substance use disorder
- Active or recent history of eating disorder, recent weight change of \>10%
- Women: pregnancy (current or planned), breastfeeding, \< 1 year postpartum
- Use of hydroxyurea
- Extensive skin changes or adhesive allergy making CGM sensor use problematic
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06067139
Start Date
August 1 2023
End Date
December 1 2027
Last Update
December 15 2025
Active Locations (1)
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1
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227